Annovis Bio, Inc. announced that AD phase II/III study of its lead compound buntanetap has exceeded full enrollment. Since the initiation of phase II/III study in March 2023, over 700 patients were screened and a total of 353 patients enrolled across 54 sites in the United States. The phase II/III study is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD.

This is a dose ranging study where patients receive either one of three doses of buntanetap (7.5mg, 15mg, or 30mg) or placebo on top of their standard of care for 12 weeks. Buntanetap's mechanism of action, favorable toxicology profile, and oral mode of administration distinguish it as superior to other AD drugs. Other drugs attempt to remove just one neurotoxic protein and, at best, have a minor effect.

Buntanetap reduces levels of multiple neurotoxic proteins - Amyloid Beta, Tau, alpha Synuclein, and TDP43 - therefore improving synaptic transmission and axonal transport and reducing inflammation, which has been shown to be the cause of cell death. By attacking several pathways involved in neurodegeneration, buntanetap has the ability to reverse the destructive effects that Alzheimer's Disease has on thinking and memory. Annovis announced on October 12, 2023, the positive efficacy interim analysis and on October 30, 2023, the safety review by the Data and Safety Monitoring Board (DSMB).

The efficacy and safety analysis reviewed by the DSMB recommended that Annovis continue the trial as originally designed. Company expect the data from this study to read out by the end of March 2024.